Medical support system

ABSTRACT

A medical support system and method for performing at least one medical support process relating to diagnosis and treatment of a medical condition and that includes or employs medical records relating to patients and medical support databases including medical guidelines for the diagnosis and treatment of a medical condition. A medical support process includes one or more process phases, which may include a data phase, a diagnostic phase and a therapy/treatment recommendation phase. Each process phase includes one or more process operations wherein each of the process operations of a process phase includes one or more process forms providing interfaces between a user and the process operations. Each process form includes fields for passing user inputs to the process operations and for displaying the results of the process operations to the user and the support processes are responsive to user inputs, the medical records and the guidelines to execute an interactive dialogue between the medical support process and the user to provide guidance to the user in performing the medical support process according to the guidelines and dependent upon the user inputs and the medical record.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application relates to and claims the benefit of priority asa continuation of U.S. patent application Ser. No. 10/017,652, filed onDec. 12, 2001, entitled “Medical Support System,” which is hereinincorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention is related to a method and system for serviceprovider support in providing services involving complex interplay offactors, recommendations and guidelines and requirements from a range ofsources, including judgment decisions, and in particular forinformation, decisions and reporting support in the providing of medicalservices.

BACKGROUND OF THE INVENTION

Many professions require that practitioners and para-practitioners makejudgments and decisions based upon or influenced by a complex interplayof information, factors and requirements from a range of sources and asthe result of executing complex procedures which in themselves mayinvolve complex and even conflicting requirements. A typical example isthe medical profession, wherein a doctor or paramedical, such as a nursepractitioner, is required to acquire and consider a large volume ofpresent and historical patient information and to decide, based on thatinformation, whether to acquire further information and what proceduresor methods to use in acquiring the additional information. Thepractitioner is then required to evaluate the patients present andprobable future conditions and trends or developments, and to decidewhether changes in treatment are necessary and what those changes shouldbe. These processes are further complicated in that the practitioner ispresented with a continuous flow or even flood of new and continuouslychanging information, recommendations and requirements.

For example, there are one or more professional associations or groupsassociated with virtually every significant medical condition ordisease. Each of these groups or organizations is engaged in the studyof the disease of interest and in the generation of recommendations andguidelines for the treatment of the disease, which change frequently asmore is learned about the disease. The medical treatment industry,including pharmaceutical companies, medical equipment companies,hospitals and other medical treatment related enterprises are in turnengaged in the continuous development of new medications and methods fortreatment of diseases or medical conditions, and recommendations for theuse of the new medications or methods. Yet other organizations, such asthe medical insurance organizations of various types, issue medicaltreatment guidelines based upon the guidelines developed by theprofessional organizations and medical industry and upon their ownrequirements and goals. These goals and requirements not only changecontinuously, but may conflict with the guidelines and recommendationsof, for example, the professional organizations or those of otherinsurance organizations.

As a result, the practitioner is faced with increasingly complexdecision making processes, involving increasing volumes and types ofinformation and sources of information, increasing and continuouslychanging guidelines and requirements, increasing numbers of medicationsand methods for treatment, and increasingly numerous and more complexdecision points in the processes for providing care to a patient. Theseproblems are further compounded in that the guidelines or requirementsof the various organizations often disagree or are in conflict. Forexample, a professional organization may recommend one medication fortreatment of a condition, one insurance company may require a secondmedication, and another insurance company may approve only a thirdmedication. These guidelines and requirements, however, are typicallybased upon generalized, statistical information gathered from studiesand represent “average” patients and conditions. The guidelines alsotend to be influenced by the specific interests of each group, such ashealth insurance or management organizations with a strong interest incost containment. The doctor, however, is most familiar with thespecific patient and the current condition and history of the patient,and may recognize that a different medication or course of treatment ispreferable. The problem is still further compounded in that many of thegroups and organizations supporting the practitioner, such asprofessional organizations, the pharmaceutical companies and theinsurance companies, also request or require increasing volumes ofreports from the practitioners, further increasing the workloads on thepractitioners.

As a consequence, practitioners are often overwhelmed with a flood ofinformation regarding each specific patient, the current and changingtests, guidelines, recommendations, medications and treatments forvarious diseases or conditions, conflict among the requirements orrecommendations of various professional or service organizations, andthe various reporting requirements or requests. As a result, and despiteexperience, thorough professional training and all due care on the partof the practitioner, it is possible for a practitioner to miss or forgeta factor, a test, a possible medication or a requirement or a guidelinesimply because of the number of factors to consider for a given patientand the current range and complexity of possible medical procedures,even within a specific disease or condition. A practitioner may, forexample, overlook or be unaware of indications of a developingcondition, a precautionary or recommended test, a possible medication ormedication conflict, a changed guideline, or avoidable conflicts withrecommendations, guidelines or reporting requirements. For example, anewly changed guideline may warn that a change in or value of a bloodtest factor that was previously held to be insignificant is now regardedas a warning or indicator of a condition for which a precautionary testis recommended. In a further example, certain insurance companies mayapprove payment for specific medications but not for equivalentmedications, thereby leading to possible conflicts with insurancecompany requirements that could be avoided.

Various practitioner support systems of the prior art, such as recordgeneration/retrieval systems, information retrieval systems and “expert”systems, have attempted to address these problems. Such systems of theprior art have generally been of only limited success, however, becausethey either do not address or only partially address the actual needsand methods of practice of the practitioners.

For example, electronic medical record (EMR) systems are in common useto generate and retrieve on-line medical records for individualpatients. Such EMR systems, however, do not assist the practitioner inperforming medical examination and treatment processes, often referredto as “patient encounters”, but typically assist only by providing faststorage and retrieval of historical information pertaining to a patient.Because of the range and variety of medical information that couldpossibly be stored for a given patient, however, it is very difficult tocreate and maintain an electronic medical record having all of thenecessary data storage fields for each patient and it is very difficultand time consuming to enter the medical data, such as test results andmedications prescribed. As a result, EMR systems are often not used totheir full potential. For example, many users attempt to implement paperrecord work flows in an EMR system, but fail to capture the true powerof the EMR system, such as the digital storage of data which can beimported, exported, extracted and integrated to improve work flow andquality of care.

In a like manner, there are many on-line information retrieval systemsavailable to the practitioner and through which a practitioner maysearch for and retrieve information pertaining to diagnostic symptoms,guidelines for treatment, medications and medication effects, insurancepolicies and requirements, and so on. While such information retrievalsystems provide wide access to a vastly increased range of information,such systems are essentially merely substitutes for traditional hardcopy references, such as the Merck manual. Again, such systems are tooslow and cumbersome to be of assistance to the practitioner in real timepatient encounters and many, if not most practitioners, tend to relyupon their experience and memory for such information during patientencounters or to refer to a hard copy of a reference work.

Lastly, there have been many attempts to create “expert” or “artificialintelligence” systems to aid medical practitioners, but such systemshave been typically unsuccessful in practice for a number of fundamentalreasons.

For example, “expert” systems which attempt to distill and provide theexpertise of one or more experts in a given field are difficult tocreate because it is difficult, if not impossible, to insure that all ofthe required expert knowledge has in fact been extracted and embodied inthe system. That is, and for example, a single expert may not have allof the desired knowledge, particularly in a large and complex field, andexperts often disagree on essential matters, such as conditions fordiagnosis and optimum treatment plans. In addition, human thoughtprocesses are extremely complex and are not well understood and expertsoften do not consciously understand how their minds reach a conclusionor retrieve a necessary bit of information. For example, a specificpattern of information may trigger an unconscious thought process andthe retrieval of a critical bit of knowledge. The expert may be unawareof knowing that critical bit of knowledge on a conscious level, and theremembering may occur only for a very specific pattern of stimulus, sothat it is virtually impossible to deliberately retrieve thatinformation for inclusion in an expert system. For the same reasons, itis very difficult to maintain, update or correct such expert systems asknowledge and practices evolve.

While expert systems attempt to assist the practitioner by extending thepractitioner's knowledge and, for example, analytical skills,“artificial intelligence” (AI) systems attempt to emulate the thoughtprocesses of the practitioner and to effectively either replace thepractitioner or place a second practitioner at the human practitioner'sshoulder. Artificial intelligence systems, however, not only have all ofthe problems of expert systems with regard to extracting and embodyingknowledge, but also have unique problems that limit their use in manyfields. For example, many AI systems are designed for and capable of“learning” or self-modification over time and with “experience”. Whilethis is one of the advantages and desired features of AI systems, it canbe a problem in many applications due to uncertainty over time withrespect to the rules, principles and information through which and uponwhich a system is currently providing advice or decisions. For thesereasons, AI systems are often regarded as too uncertain or unreliablefor certain applications, such as medical support services. There arealso psychological problems with AI systems as practitioners areuncomfortable with systems that apparently attempt to replace thepractitioners, or to at least displace or “second guess” their primaryfunction, and patients are often uncomfortable dealing solely orprimarily with a computer system rather than a human in medical matters.

The present invention provides a solution to these and other relatedproblems of the prior art.

SUMMARY OF THE INVENTION

The present invention is directed to a medical support system and methodfor providing medical support for performing at least one medicalsupport process relating to diagnosis and treatment of a medicalcondition.

According to the present invention, the system and method of the presentinvention includes or employs at least one medical record relating to apatient and at least one medical support database including medicalguidelines for the diagnosis and treatment of the medical condition andperforms a medical support process including at least one process phase.In the present invention, each process phase includes one or moreprocess operations wherein each of the process operations of a processphase includes at least one process form. Each process form provides aninterface between a user and the process operations of the process phaseand each process form includes fields for passing user inputs to theprocess operations and for displaying the results of the processoperations to the user wherein at least one support process isresponsive to user inputs, the medical record and the guidelines forperforming the process operations. The support processes thereby executean interactive dialogue between the medical support process and the userto provide guidance to the user in performing the medical supportprocess according to the guidelines and dependent upon the user inputsand the medical record.

According to the present invention, a medical support process typicallyincludes a data phase for entering new information and reviewinghistorical information pertaining to the medical condition of thepatient for the purposes of the medical support process, and anassessment phase for evaluation of the patient's present medicalcondition based upon the information from the data phase and theguidelines for the diagnosis and treatment of the medical condition. Amedical support process may further include a recommendations phaseincluding process operations and guidelines to assist the user indetermining a course of treatment for the patient.

The process form fields include fields for the display and entry ofdata, text, prompts, messages and user decision options and may includeprocess fields containing process calls invoking corresponding supportprocesses upon corresponding user inputs to the process fields.

The support operations may include first support processes for invokingsecond support processes dependent upon user inputs, support processesfor displaying a next process form, and support processes for modifyingthe information displayed in a present process form.

In further implementations of the present invention, the medical supportdatabases may reside within the support processes, and a medical supportsystem may include a dialect translator for translating between medicalterms displayed to and entered by a user and corresponding equivalent,but different medical terms employed in the support operations.

The present invention addresses these and other problems of the priorart.

DESCRIPTION OF THE DRAWINGS

Other features, objects and advantages of the present invention will beunderstood by those of ordinary skill in the relevant arts after readingthe following descriptions of a presently preferred embodiment of thepresent invention, and after examination of the drawings, wherein:

FIG. 1 is a block diagram of an exemplary system in which the presentinvention may be implemented;

FIG. 2 is a block diagram illustrating a medical support system of thepresent invention;

FIG. 3 is a block diagram illustrating medical support processes of thepresent invention;

FIGS. 4A through 4M illustrate process forms and process form fields foran exemplary medical support process; and

FIG. 5 is a flow diagram illustrating the generation and maintenance ofa medical support process.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 and 2, therein is shown illustrative block diagramsof an exemplary Medical Support System (MSS) 10 implementing the presentinvention.

As indicated in FIG. 1, an MSS 10 will typically be implemented in ageneral purpose Computer System 10CS that will typically include aProcessor Unit 10PU, a Memory 10MM with one or more associated MassStorage Device 10MS for storing Programs 10PG and Data 10DT, one or moreInput Devices 10ID for user inputs, such as a keyboard, mouse or touchscreen, and a Display 10DS for display of information to a user. A MSS10 may be implemented in, for example, a desktop, laptop or notebookcomputer, as terminals or computers networked with data and programServers 10SS through local or wide area Networks 10NN, includingwireless networks, or in wireless networked palmtop devices ofappropriate memory, processing and display capacity.

As will be well understood by those of ordinary skill in the relevantarts, a MSS 10 will perform or execute Processes 10PR controlling,performing or supporting the functions and operations of the MSS 10,including, for example, the medical support system processes. TheProcesses 10PR of a MSS 10 will typically include, for example,Administrative Processes 10APR pertaining to the administrative andmanagement functions of the MSS 10, such as operating system functions,and Medical Processes 10MED comprising the medical support systemfunctions of the present invention. Processes 10PR are defined andcontrolled by Programs 10PG and, for example, user data input providedthrough Input Devices 10ID and data read from databases or other datasources, may reside in one or more Mass Storage Devices 10MS.

As will be described in the following, the Medical Processes 10MEDcomprising the medical support system functions of the present inventionis not constrained to the generation and maintenance of patient medicalrecords, although these operations are within the scope of functionssupported by the Medical Processes 10MED. Instead, a MSS 10 of thepresent invention provides real time, interactive support forpractitioners during patient encounters, such as prompts and remindersof necessary information or tests, advice and guidelines in diagnosisand treatment, decision support, therapeutic recommendations,educational information and the real time capture of metrics. Thesupport provided by a MSS 10 of the present invention is based, forexample, upon the best current recommendations of, for example,professional medical organizations, studies, health care/insuranceguidelines, and so on. In this regard, however, a MSS 10 of the presentinvention does not attempt to supplant or replace the experience andjudgment of the practitioner, but instead operates to maximize theworkflow, mind flow and quality of practice by advisory support whichmay be overridden by the practitioner at any time based, for example, onthe practitioner's experience or more specific knowledge regarding aparticular patient.

According to the present invention, the system and method of the presentinvention includes or employs medical records relating to the patientsand medical support databases including medical guidelines for thediagnosis and treatment of medical conditions according to currentprofessional guidelines for the diagnosis and treatment of diseases andmedical conditions and processes utilizing these databases to diagnoseand recommend therapy or treatment for a patient in a manner that issupportive of but that does not interfere with the work and mind flowprocesses of the user. As will be described, a support process performedby a medical support system of the present invention executes aninteractive dialogue between the medical support process and the user toprovide guidance to the user in performing the medical support processaccording to the guidelines and dependent upon the user inputs and themedical record. A medical support process performed by the presentinvention for a given condition or disease includes one or more processphases, which may include a data entry and review phase, a diagnosticphase and a therapeutic/treatment recommendation phase, which arepresented to a user through process forms providing graphic interfacesfor the entry and display of information regarding the support process.

Referring to FIG. 2, it is illustrated therein that in a presentlypreferred and typical embodiment of a MSS 10, the Medical Processes10MED of the present invention are constructed on and use the facilitiesand functions of a conventional Electronic Medical Record System (EMR)12, such as MedicaLogic/Medscape Logician® from MedicaLogic/MedscapeCorporation, and a conventional Database Program 14, such as an Oracle®server relational database. As is well understood in the relevant arts,in a conventional medical record system EMRs 12 and Database Programs 14operate on an Operating Systems 16, such as Microsoft Windows®), andwith either a thick or thin Client Interface 18, to construct, manage,store and retrieve patient medical records. It will be understood,however, that MedicaLogic/Medscape Logician® and the Oracle® databaseare representative and exemplary of a range of readily available,conventional electronic medical record programs and databases used toconstruct, manage, store and retrieve patient medical records. It willalso be understood that these functions of a MSS 10 may be implementedthrough any similar or equivalent programs, or through correspondingprograms generated specifically for a MSS 10.

As illustrated in FIG. 2, an EMR 12 typically includes an InterfaceMechanism 20 which comprises a plurality of mechanisms and functions forentering data into and reading data from the associated databases. InMedicaLogic/Medscape Logician®, for example, this mechanism is referredto as the MedicaLogic Expression Language (MEL) and comprises a softwarecode platform that allows input to and output from the relationaldatabase. An Interface Mechanism 20 will typically include a Language20L which comprises defined terms and syntax for defining databaserecords, the fields and contents of the database records, formulatingqueries and searches of the database records, relating and parsing thefields and contents of the database records, reading data from andentering data into the database records, and so on.

Interface Mechanism 20 will typically also include an Interface FormEditor 22 for the generation and construction of graphical userinterfaces and displays of, for example, processes and database recordssupported and executed by the EMR 12 and associated databases. Such userinterfaces and displays are typically structured and displayed as Forms22 wherein a Form 22 comprises a structured array of Fields 24 for thedisplay and entry of data, text, graphics, prompts, messages, “pop-upwindows”, and so on, to display to a user and to allow a user tointeract with, for example, Medical Processes 10MED and the associateddatabases. For example, a user may enter data identifying a patient intocertain Fields 24 of an initial Form 22 through Input Devices 10ID andInterface Mechanism 20 will read and parse the data in the Fields 24 ofthe Form 22, query the associated databases with the data, and read outand display information pertaining to that patient, either in the sameForm 22 or in another Form 22. The user may then enter additional datainto that or an associated Form 22, such as an identification of thepurpose of the current patient encounter, such as a periodic review andassessment of the patient's lipid levels. Interface Mechanism 20 willthen call up and display one or more Forms 22 having Fields 24displaying relevant information, such as data from the patient's medicalrecords or the results of new tests, and so on. The user may then, forexample, review the historical data, compare the historical data to newdata, or enter new data, and so on. Interface Form Editors 22, such asthe Encounter Form Editor® provided in MedicaLogic/Medscape Logician®,are well known in the art and need not be discussed in further detailfurther herein.

As illustrated in FIG. 2, Medical Processes 10MED of the presentinvention include one or more Medical Support Processes 10MSP and one ormore associated Medical Databases 10MDB wherein Medical Databases 10MDBinclude Medical Record Databases 28 and may include one or more MedicalSupport Databases 30. Medical Record Databases 28 may include one ormore Medical Records 28R for and corresponding to each patient,depending upon types and sources of information comprising eachpatient's records. Medical Record Databases 28 are constructed and usedin the conventional manner to store, manage and retrieve patient MedicalRecords 28R and are, for example, generated, stored, managed andretrieved by and through EMR 12, as discussed briefly above. MedicalSupport Databases 30, in turn, contain medical information used in themedical support functions described below and may be constructed orprovided from a variety of sources, but typically may be accessed by EMR12 or EMR 12 related mechanisms of the MSS 10, such as InterfaceMechanism 20. As will be described in the following, Medical SupportDatabases 30 may be implemented in a variety of forms, such as separatedatabases for the various types of medical support processes provided oras data integrated into the medical support processes.

Next considering the Medical Support Processes 10MSP provided andexecuted by a MSS 10 of the present invention, it is recognized thateach interaction between a medical practitioner and a patient may beregarded as comprising one or more “encounters”. An “encounter” may inturn be defined as a procedure of one or more steps that are primarilyfocused upon or involved with a given medical issue and the encountersmay be of variable scope or complexity. For example, a general primaryphysical examination comprises one or more encounters of relatively widescope, encompassing a wide range of medical information, but ofrelatively low complexity, such as testing or determining whether avariety of basic medical variables are within accepted ranges Otherencounters may be of lesser scope but greater depth, such as anencounter focused on control of lipid levels or of an asthma treatment,or may comprise several encounters which may be independent of oneanother or which may overlap or be related.

Referring to FIG. 3, in a presently preferred embodiment of a MSS 10,Medical Processes 10MED include and support one or more Medical SupportProcesses 10MSP wherein each Medical Support Process 10MSP correspondsto a specific type of encounter. For example, one Medical SupportProcess 10MSP may implement a medical process for the control of lipidlevels while another may implement procedures for the evaluation,diagnosis and treatment of asthma or a cardiac condition. As illustratedin FIG. 3, a Medical Support Process 10MSP comprises a plurality ofProcess Phases 32 wherein each Process Phase 32 is focused on a certainaspect or aspects of the Medical Support Process 10MSP and comprises oneor more Process Operations 32O. For example, a typical Medical SupportProcess 10MSP may include two basic Process Phases 32, respectivelyreferred to as the Data Capture (Data) Phase 34 and theAssessment/Diagnosis (Assessment) Phase 36, and may include a thirdbasic Process Phase 32, referred to as the Recommendations Phase 38.

A Data Phase 34 is generally comprised of operations to acquire, enterand review historical and new information pertaining to the medicalcondition of a patient for the purposes of the current encounter, andmay typically be performed by a nurse or para-practitioner. Suchoperations may include, for example, entry of the current date, entry ofcurrent measurements, such as blood pressure and heart rate, the entryor confirmation of entry of current or recent tests or procedures, suchas blood or cholesterol screening, the entry of information from thepatient, such as recent number and severity of asthma attacks, and soon, and the review of the present and historical information, includingmedication and other treatment plans. The procedures of Data Phase 34will often include the generation of prompts and reminders to the user.Such prompts and reminders will typically be dependent upon the purposeof the encounter and, for example, may insure that information necessaryto or desirable the procedure are acquired and entered. For example, theuser may be prompted to determine and enter a current blood pressure,heart rate and weight, to ask certain relevant questions of the patient,such as the patient's perceptions of the effects of a medication, and soon.

The Assessment Phase 36 would typically be performed by a practitioneror para-practitioner and is essentially comprised of procedures toassess the patient's condition and treatment based upon the informationacquired or updated in Data Phase 34 and, for example, to assist in thediagnosis of the patient's condition and treatment. For example,procedures of Assessment Phase 36 may present medical guidelines forassessment and treatment of the severity or level of a patient'scondition based upon current information and may suggest tests orprocedures to be performed or that should be performed at regularintervals or that are due to be performed Assessment Phase 36 may alsoinclude procedures to suggest reminders of other conditions that mayarise from or be related to the patient's current condition or that mayresult in similar symptoms and should be considered, and so on Otherinformation provided to the user may include suggested medications,including the effects, side effects and interaction effects of themedications, reminders of medications that have been used previously orother medications currently being used by the patient for other reasons,and so on. As described herein above, however, all such reminders,suggestions and prompts are presented to the practitioner as remindersand suggestions and the user may override such reminders, suggestionsand prompts based, for example, the practitioner's experience orknowledge of the particular patient or of other factors, and willtypically be provided with fields to enter the reasons for disagreementwith the guidelines, which will be automatically entered in thepatient's Medical Records 28R as a reminder to the practitioner at thenext encounter with the patient.

A Medical Support Process 10MSP may also include a Recommendations Phase38, which is typically primarily comprised of procedures to assist thepractitioner in determining a course of treatment for the patient, basedupon currently accepted guidelines and standards of practice in thefield and for the condition of interest. These procedures may provideguidelines regarding possible medications and recommended medicationlevels, including the effects, side effects and interaction effects ofthe medications, reminders of medications that have been used previouslyor other medications currently being used by the patient for otherreasons, suggestions for forms of treatment, suggestions for furthertests and similar procedures, and so on. Although many of theRecommendations Phase 38 procedures may overlap procedures that mayappear in the associated Assessment Phase 36, the procedures of theRecommendations Phase 38 will typically be in greater depth and at agreater level of detail than will those of the Assessment Phase 36.

It must be noted that a Recommendations Phase 38 may not be necessaryfor a given Medical Support Process 10MSP, or could be an extensivesupplement to the Medical Support Process 10MSP, depending on theproblem, condition or disease addressed by the Medical Support Process10MSP. It must also be noted that the Process Operations 32O of aRecommendations Phase 38 will operate to thoroughly integrate thedecision and recommendation support prompts and suggestions provided bythe Recommendations Phase 38 with the patient specific information,including both the historical information acquired from Medical Records28R and the current information acquired in the Data Phase 34, so thatall recommendations, suggestions and prompts are specific to andtailored to that patient at that time. For example, the patient specificinformation evaluated includes but is not limited to patientdemographics, such as age, sex, height, weight, and so on, problemsparticular and specific to the patient, current and previousmedications, allergies, lab values, that is, the results of laboratorytests and procedures, and patient specific observations, such as whetherlipid goals have been met, and so on.

It will be apparent that the number, arrangement and relationshipsbetween Process Phases 32 in a Medical Support Process 10MSP will dependupon the nature, scope and complexity of the Medical Support Process10MSP and of the encounter. For example, in certain Medical SupportProcesses 10MSP the Data Phase 34 and the Assessment Phase 36 or theAssessment Phase 36 and the Recommendations Phase 38 may be integratedor combined into a single Process State 32, or certain Process Phases32, such as a Recommendations Phase 38, may not be required in a givenMedical Support Process 10MSP. It will also be apparent that a givenMedical Support Process 10MSP may include additional Process Phases 32for specific purposes, or that a given Process Phase 32 may be organizedas a number of Process sub-Phases 32 for convenience, ease of use orclarity. It will also be recognized that the number, design, arrangementand relationship among the Process Forms 40 of each Process Phase 32will be dependent upon similar factors and judgments, as well as suchfactors as the graphics display capabilities of the Output Devices 10ODof the MSS 10 in which the Medical Support Processes 10MSP areimplemented. For example, a laptop to a desktop computer with relativehigh graphic display capabilities may arrange and display moreinformation in each Process Form 40, while the more limited capabilitiesof, for example, a palmtop device or even a cell phone type device mayrequire that the Process Phases 32 be implemented through a greaternumber of simpler Process Forms 40.

In a typical implementation of a Medical Support Process 10MSP, theProcess Phases 32 and Process Operations 32O of the Medical SupportProcesses 10MSP are implemented and executed through Process Forms 40and associated Support Processes 44, together with the Medical Records28R and Medical Support Databases 30 associated with the ProcessOperations 32O.

Process Forms 40 and Interface Mechanism 20 comprise the interface andmechanism through which a user interacts with the Process Operations 32Ocomprising each Process Phase 32 of a Medical Support Process 10MSP. Asdescribed, each Process Form 40 comprises a structured array of Fields42 for the display and entry of data, text, graphics, prompts, messages,commands, “pop-up windows”, and so on. For example, a Medical SupportProcess 10MSP may be initially represented by an initial Process Form 40which presents an index of the Process Phases 32 comprising the MedicalSupport Process 10MSP, and “clicking” on an index tab or field may callup the first of one or more Process Forms 40 comprising the selectedProcess Phase 32. Within a Process Form 40 of a Process Phase 32, and asdiscussed further below, the user will be presented with Fields 42 forinteracting with one or more Process Operations 32O comprising theProcess Phase 32, such as Fields 42 for entering and displayinginformation or prompts pertaining to one or more Process Operations 32O.Process Forms 40 may be created, for example, by the Interface FormEditor 22 of the Interface Mechanism 20 of the EMR 12, although aProcess Form Editor 40E similar to an Interface Form Editor 22 may becreated specifically for this purpose.

Next considering Support Processes 44, the Process Operations 32O ofeach Process Phase 32, are implemented by and in Support Processes 44,each of which is an interactive process or program for performing aProcess Operation 320. In this regard, and as indicated in FIG. 3,certain Fields 42 of Process Forms 40, indicated as Process Fields 46,contain Process Calls 48 wherein each Process Call 48 is a reference,designator, “call” or invocation to or of a corresponding SupportProcess 44. That is, and for example, an action with respect to aProcess Field 46, such as the entry of data or of a decision or command,including “clicking” on the Process Field 46 to invoke a correspondingaction or activity, will in turn invoke or call a corresponding SupportProcess 44. In another instance, a Support Process 44 may invoke anotherSupport Process 44, the selection of may be dependent upon the natureand results of the calling Support Process 44. In another example,multiple Process Fields 46 may refer to the same Support Process 44, aswhen two or more Process Fields 46 of a Process Form 40 invoke a SupportProcess 44 that invokes the next Process Form 40 in a sequence or groupof Process Forms 40. In other instances, and again for example, thevalue or decision entered into a Process Field 46 may determine theSupport Process 44 that is called, as when the entry of a value ordecision in a Process Field 46 calls a Support Process 44 that checksthe value or decision entered in a Process Field 46 and the result ofthe check determines the path of execution through the Support Process44, or another Support Process 44 to be invoked. In other examples,Support Processes 44 may confirm that all necessary data is present inthe Fields 42 of a Process Form 40, whether the time elapsed since aperiodic test or procedure was last performed has exceeded recommendedlimits, or whether the test or procedure was performed at all. OtherSupport Processes 44 may compare the values contained in Fields 42, suchas current diagnostic or test conditions and medication types of levels,and may display a prompt or suggestion or diagnosis when the valuesindicate a potential problem or suggest a medication or change inmedication, and so on. Those of ordinary skill in the relevant arts willthereby appreciate that Support Processes 44 and Process Forms 40 allowthe construction of Process Operations 320 and Medical Support Process10MSP of any desired extent or complexity.

Finally, Medical Records 28R and the Medical Support Databases 30, theMedical Records 28R involved in the performance of a Medical SupportProcess 10MSP will be comprised of the Medical Records 28R of thepatient that is the subject of the encounter and will typically includethe patient's historical Medical Records 28R, together with new datapertaining to the patient, such as reports containing the results ofcurrent or recent tests or procedures. As described herein above, thepatient Medical Records 28R will typically be accessed through InterfaceMechanism 20 of the EMR 12 to read data from the Medical Records 28R orto enter data into the Medical Records 28R, either as a result of userinputs through Input Devices 10ID or by operation of one or more ofSupport Processes 44.

Medical Support Databases 30, in turn, contain medical information usedin the execution of Support Processes 44. Medical Support Databases 30will contain, for example, ranges or values of biological measurements,such as blood pressure, lipid levels or frequency and severity of asthmaattacks that represent, according to current medical guidelines, eitheracceptable ranges or ranges indicating a diagnosis of a condition to betreated, guidelines for medications and medication levels, guidelinesfor tests or other procedures, including guidelines as to the frequencyof tests and procedures, and so on. As described herein above, MedicalSupport Databases 30 may be constructed or provided from a variety ofsources, and may be accessed, for example, through the InterfaceMechanism 20 of the EMR 12 or equivalent mechanisms. Medical SupportDatabases 30 will typically be accessed by operation of and throughSupport Processes 44, although user inputs through Input Devices 10IDmay be used to directly access Medical Support Databases 30 in certaincircumstances.

It will be appreciated and understood by those of ordinary skill in therelevant arts that Process Forms 40 and Medical Records 28R may beconstructed, maintained and accessed by means of, for example, anInterface Form Editor 22 of an Interface Mechanism 20 of an EMR 12, orby similar mechanisms. It will also be appreciated and understood bythose of ordinary skill in the relevant arts that Support Processes 44and Medical Support Databases 30 may be implemented in a variety offorms and by use of a variety of utilities or tools, including anInterface Form Editor 22 of an EMR 12 as the Interface Mechanisms 20 ofmany EMR 12s support at least some degree of programming capability.

In this regard, Support Processes 44 and Medical Support Databases 30may be constructed as separate entities, that is, as a library ofprocesses, programs or routines for performing Process Operations 32Oand as one or more databases containing information extracted fromcurrent medical practice guidelines or recommendations that is accessedas required by the Support Processes 44. As discussed, the informationincluded in Medical Support Databases 30 may include, for example,ranges or values of biological measurements, such as blood pressure,lipid levels or frequency and severity of asthma attacks that represent,according to current medical guidelines, either acceptable ranges orranges indicating a diagnosis of a condition to be treated, guidelinesfor medications and medication levels, guidelines for tests or otherprocedures, including guidelines as to the frequency of tests andprocedures, and so on. This method for implementing Support Processes 44and Medical Support Databases 30 is generally advantageous in allowingSupport Processes 44 and Medical Support Databases 30 to be readily andindependently modified, updated or extended as needed. A disadvantage ofthis method, however, is that the construction of Support Processes 44and Medical Support Databases 30 is by processes more familiar to aprogrammer than to a medical practitioner, and that is thereby distancedfrom the methods and patterns of thought and practice of the medicalpractitioner, who is the primary user of the system and the primarysource of information regarding the procedures that are to beimplemented in Medical Support Processes 10MSP.

For the above reasons, Support Processes 44 and Medical SupportDatabases 30 are implemented in a presently preferred embodiment of MSS10 in a form and by a procedure that more closely reflects the methodsand patterns of thought and practice of the medical practitioner. Forthis reason, Support Processes 44, Process Forms 40 and Medical SupportProcesses 10MSP may be readily constructed by persons whose primarytraining and experience are in the medical rather than in programming,while is advantageous in that the Medical Support Processes 10MSP moreclosely reflect actual medical practice. More specifically, SupportProcesses 44 are presently implemented as sequences of “if-then-else”programs or procedures while and the data of Medical Support Databases30 is integrated directly into the “if-then-else” statements, or intoFields 42 or “windows” of Process Forms 40.

Lastly, it will be noted that it is common for medical practitioners touse variant forms or terms in referring to, for example, a procedure,measurement, test, medication or condition. The specific form or termused by a practitioner may depend, for example, upon the age andexperience of the practitioner, when and where the practitioner attendedmedical school or subsequently practiced, and so on. For this reason, aMSS 10 of the present invention may further include a Dialect Translator50 operating in conjunction with Interface Mechanism 20 to translatebetween terms and forms used by a given practitioner and a common,standard or standardized set of terms and forms. Dialect Translator 50includes a Dialect Text File 50D for each practitioner using a given MSS10 wherein the Dialect Text File 50D contains standardized terms andforms as used in Process Forms 40 and wherein the Dialect Text File 50Dis indexed by terms and forms specified by or for a given practitioner.Dialect Translator receives terms and forms entered by that practitionerthrough Input Devices 10ID, and provides the corresponding standard termor form. Dialect Translator 50 also operates in the reverse by readingstandard terms and forms appearing in Process Forms 40 and translatingthe standard terms and forms into the dialect terms and forms preferredby the practitioner in the Process Forms 40 as displayed to thepractitioner through Display 10DS.

Lastly, in this regard, FIGS. 4A through 4B comprise illustrations ofProcess Forms 40, the Fields 42 and Process Fields 46 of the ProcessForms 40, and Support Processes 44 of an exemplary Medical SupportProcess 10MSP and, in particular, a Medical Support Process 10MSP forthe monitoring and control of lipids, which is a generally recognizedsignificant medical problem. In FIGS. 4A through 4M, FIGS. 4A through 4Killustrate the Process Forms 40 of a Process Phase 32 in which the DataPhase 34 and Diagnostic Phase 36 of the Medical Support Process 10MSPare interleaved, but which begins with Process Forms 40 primarilydirected to Data Phase 34 processes and shifts toward Diagnostic Phase36 processes. For example, and it will be noted that each of theseProcess Forms 40 contains fields for displaying and entering informationrelating to the patient, such as age, related conditions or diseases,current cholesterol, LDL, HDL and triglyceride levels, and goalcholesterol, LDL, HDL and triglyceride levels, either as yes/nodecisions/data or as numeric data, and so on. In FIG. 4A, for example,the user is prompted to enter a diagnosis of hyperlipidemia to thepatient problem list, if appropriate. In FIG. 4B the user requests thecurrent professional guidelines for cholesterol, LDL, HDL andtriglyceride levels if the patient is diabetic, and in FIG. 4C repeatsthe process of Step 4B for additional risk factors. In FIG. 4D the userrequests that the patients most recent lab measurements be displayed,for example, for comparison with the guideline cholesterol, LDL, HDL andtriglyceride levels, and in FIG. 4E the user requests the cholesterol,LDL, HDL and triglyceride level guidelines for the patient's currentrisk factors. In FIGS. 4F and 4G, the user requests informationpertaining to the diagnosis steps performed in FIGS. 4A through 4E byrequesting information regarding the categories of risks that were usedin determining the patient risk profile. FIGS. 4F and 4G respectivelyillustrate the system responses for CV risk factors of 6% and 21%, andin FIG. 4H the Medical Support Process 10MSP provides the user with amessage further explaining the risk factors. In FIGS. 4I and 4J the userand support process have reverted to the Process Form 40 illustrated inFIG. 4A, but which is now modified to provide user prompts/reminders asto whether the user has considered other causes of hyperlipidemia and,upon query by the user, displays two message pages of informationrelating to secondary causes of hyperlipidemia, wherein the user canenter information regarding those factors considered by the user. FIG. 4k continues this process by providing criteria for recommended periodsor intervals for repeated lipid profiles for various conditions. InFIGS. 4L and 4M, the Medical Support Process 10MSP enters aRecommendations Phase 38 wherein the Medical Support Process 10MSPprovides messages containing therapy or treatment/medicationrecommendations based on current professional guidelines and the patientinformation and diagnosis that were entered or reached in the Data Phase34 and Diagnosis Phase 36 illustrated in FIGS. 4A through 4J.

Lastly, in this regard, Appendix A to the Specification contains alisting of the “if-then-else” statements comprising the SupportProcesses 44 for the Medical Support Process 10MSP, illustrated in FIG.4, as an exemplary implementation of a Medical Support Process 10MSP.

In summary, therefore, and as illustrated and described herein above, asystem and method of the present invention include or employ medicalrecords relating to the patients and medical support databases includingmedical guidelines for the diagnosis and treatment of medical conditionsaccording to current professional guidelines for the diagnosis andtreatment of diseases and medical conditions and processes utilizingthese databases to diagnose and recommend therapy or treatment for apatient in a manner that is supportive of but that does not interferewith the work and mind flow processes of the user. As described, asupport process performed by a medical support system of the presentinvention executes an interactive dialogue between the medical supportprocess and the user to provide guidance to the user in performing themedical support process according to the guidelines and dependent uponthe user inputs and the medical record. A medical support processperformed by the present invention for a given condition or diseaseincludes one or more process phases, which may include a data entry andreview phase, a diagnostic phase and a therapeutic/treatmentrecommendations phase, which are presented to a user through processforms providing graphic interfaces for the entry and display ofinformation regarding the support process.

Finally, the procedure for constructing a Medical Support Process 10MSPis illustrated in FIG. 5 and includes the steps of:

Step 52A: Selection of a problem or disease for management and/or study.

The process of designing a guideline-assisted Medical Support Process10MSP requires selecting a problem or disease to be the subject of theMedical Support Process 10MSP. This step may be based uponevidence-based nationally recognized and published clinical practiceguidelines or upon a selected local, regional, or private criteria.

Step 52B: Review of current evidence-based studies and nationallyrecognized clinical practice guidelines, including review of theliterature.

An extensive review of the literature provides the foundation fordeveloping consensus current professionally accepted guidelinespertinent to the subject of the Medical Support Process 10MSP andcreating of the guideline-assisted Medical Support Process 10MSP. Forexample, the Agency for Healthcare Quality Research (AHQR) is presentlythe overseer of the National Guidelines Clearing House and, for example,can serve as a starting point. Peer review journals with evidence-basedoutcome studies may also be sources of guideline criteria.

Step 52C: Review of existing workflow and “mind flow” process.

The day-to-day, step-by-step workflow required in the evaluation andtreatment of the chosen problem or disease is mapped out for the averageprovider and practice and the thought process of the provider andpatient are studied to map out the most time efficient entry and displayof information, guideline prompts, and clinical decision support.

Step 52D: Creation of decision-support, workflow and “mind flow” processimprovements, and outcome study metrics.

Based on the evaluation of information gathered in Step 50C on theproblem or disease and existing work flows, improved work flow and “mindflow” processes are developed to be implemented in the Medical SupportProcess 10MSP, as are the quality and outcome study metrics to beincorporated into the Medical Support Process 10MSP.

Step 52E: Development of a guideline-assisted Medical Support Process10MSP.

Step 52E-1: A “shell” Medical Support Process 10MSP is developed whichincludes all Process Operations 32O and Process Forms 40, the qualityand outcome study metrics, and the enhanced workflow and “mind flow”processes.

Step 52E-2: A range and variety of decision support prompts are reviewedto provide the most efficient and timely but least intrusive assistance,including, for example, data displays, visibility regions and modaldialogue boxes, and the most effective are incorporated into the MedicalSupport Process 10MSP.

Step 52E-3 The work flow and “mind flow” of the Medical Support Process10MSP are reevaluated and the Medical Support Process 10MSP ispreferable then tested in real clinical practices with real patients andany corrections or modification indicated as a result of the tests areincorporated into the Medical Support Process 10MSP.

Step 52F: Development of a Recommendations Phase 38.

As described and depending on the problem, condition or diseaseaddressed by the Medical Support Process 10MSP, a Recommendations Phase38 may not be necessary or could be an extensive supplement to theMedical Support Process 10MSP. As described, in those instances where aRecommendations Phase 38 is required, Steps 52E will include theadditional Step 52F of constructing a Recommendations Phase 38 which, asdescribed, is constructed as Process Operations 320 based on series orstrings of “if-then-else” statements that evaluate past and currentpatient specific information from the databases, patient demographics,such as age, sex, height, weight, and so on, problems particular andspecific to the patient, current and previous medications, allergies,lab values, that is, the results of laboratory tests and procedures, andpatient specific observations, such as whether lipid goals have beenmet, and so on.

Step 52G: User Review.

Each Medical Support Process 10MSP is continuously reviewed on the basisof information from users of the Medical Support Process 10MSP, and ismodified as indicated by information from the users.

Step 52H: Guideline Review.

The guidelines and current recommended medical practices incorporatedinto each Medical Support Process 10MSP are continuously reviewed fromall available sources and changes in the accepted and recommendedguidelines and practices are incorporated into each Medical SupportProcess 10MSP as the recommended guidelines and practices are updated.

In conclusion, while the invention has been particularly shown anddescribed with reference to preferred embodiments of the apparatus andmethods thereof, it will be also understood by those of ordinary skillin the art that various changes, variations and modifications in form,details and implementation may be made therein without departing fromthe spirit and scope of the invention as defined by the appended claims.For example, Processes 320 and Medical Support Databases 30 may beimplemented in a wide variety of ways and forms, and the fundamentaldecision/process support mechanisms and methods of the present inventionmay be applied to and implemented for a wide range of complexanalysis/decision/procedural situations. Therefore, it is the object ofthe appended claims to cover all such variation and modifications of theinvention as come within the true spirit and scope of the invention.

1. A medical support system including: a memory storing at least onemedical support process relating to diagnosis and/or treatment of amedical condition; a processor responsive to the medical support processand to user inputs for performing the medical support process; an inputdevice receiving user input relating to the medical support process; anoutput device displaying the results of the medical support process to auser; and a bi-directional dialect translator receiving and translatingbetween preferred dialect medical terms entered by a user andcorresponding equivalent but different standard medical terms employedin the medical support process operation and, conversely,bi-directionally translating the standard medical terms employed by themedical process support operation into the preferred dialect medicalterms originally entered and used by the user for display to the user,wherein the medical support process includes: at least one process formproviding an interface between the user and process operations, eachprocess form including fields passing user input to the processoperations and displaying the results of the process operations to theuser; and at least one support process responsive to user input, patientmedical record data, and guidelines for performing the processoperations, wherein the at least support process executes an interactivedialogue between the medical support process and the user to provideguidance to the user in performing the medical support process accordingto the guidelines and dependent upon the user inputs and the medicalrecord using the bi-directional dialect translator.
 2. The system ofclaim 1, wherein the guidance provided to the user can be overridden bythe user and wherein the guidelines are dynamically updated with apatient based guideline for the individual patient based on user inputand a medical record for the individual patient.
 3. The medical supportsystem of claim 1, wherein a medical support process includes: a dataphase for entering new information and reviewing historical informationpertaining to the medical condition of the patient for the purposes ofthe medical support process; and an assessment phase for evaluation ofthe patient's present medical condition based upon the information fromthe data phase and the guidelines for the diagnosis and treatment of themedical condition.
 4. The medical support system of claim 3, wherein amedical support process further includes: a recommendations phaseincluding process operations and guidelines to assist the user indetermining a course of treatment for the patient.
 5. The medicalsupport system of claim 1, wherein the process form fields includefields for the display and entry of data, text, prompts, messages anduser decision options.
 6. The medical support system of claim 1, whereinthe process form fields include process fields containing process callsinvoking corresponding support processes upon corresponding user inputsto the process fields.
 7. The medical support system of claim 1, whereinthe support operations include first support processes for invokingsecond support processes dependent upon user inputs.
 8. The medicalsupport system of claim 1, wherein the support processes include supportprocesses for displaying a next process form.
 9. The medical supportsystem of claim 1, wherein the support processes include supportprocesses for modifying the information displayed in a present processform.
 10. The medical support system of claim 1, wherein the medicalsupport databases reside within the support processes.
 11. The medicalsupport system of claim 1, wherein user input used to override theguidance is entered in the medical record.
 12. An article of manufacturecomprising: a computer readable storage medium; and executable programinstructions embodied in the computer readable storage medium that whenexecuted by a programmable system cause the system to perform functionsthat implement a medical support system, the functions comprising: abi-directional dialect translator receiving and translating betweenpreferred dialect medical terms entered by a user and correspondingequivalent but different standard medical terms employed in a medicalsupport process and, conversely, bi-directionally translating thestandard medical terms employed by the medical support process into thepreferred dialect medical terms originally entered and used by the userfor display to the user; at least one process form providing aninterface between a user and medical support process operations, eachprocess form including fields passing user input to the medical supportprocess operations and displaying the results of the process operationsto the user; and at least one support process responsive to user input,patient medical record data, and guidelines for performing the processoperations, wherein the at least support process executes an interactivedialogue between the medical support process and the user to provideguidance to the user in performing the medical support process accordingto the guidelines and dependent upon the user inputs and the medicalrecord using the bi-directional dialect translator.
 13. The article ofmanufacture of claim 12, wherein the guidance provided to the user canbe overridden by the user and wherein the guidelines are dynamicallyupdated with a patient based guideline for the individual patient basedon user input and a medical record for the individual patient.
 14. Amethod for providing interactive support for a medical practitionerduring a patient encounter based on best currentrecommendations/guidelines, the method comprising: selecting a problemor disease to be the subject of a guidance-assisted medical supportprocess; reviewing evidence-based studies and clinical practiceguidelines to develop guidelines to support the medical support process;mapping information entry, information display, guidelines, prompts, andclinical decision support to an electronic interface form for usercompletion based on a review of an existing process workflow; creatingdecision-support and workflow processes based on the mapping; developinga guideline-assisted medical support process using the mapping, clinicaldecision support, and workflow processes; and providing the electronicinterface form and the guideline-assisted medical support process to auser for evaluation of a patient, wherein a bi-directional dialecttranslator receives and translates between preferred dialect medicalterms entered by a user and corresponding equivalent but differentstandard medical terms employed in the guideline-assisted medicalsupport process and, conversely, bi-directionally translating thestandard medical terms employed by the guideline-assisted medicalprocess support into the preferred dialect medical terms originallyentered and used by the user for display to the user.
 15. The method ofclaim 14, further comprising reviewing at least one of decision support,guidelines, and medical support process workflow based on updatedinformation from the user.
 16. The method of claim 14, furthercomprising developing a recommendations phase for the medical supportprocess including process operations and guidelines to assist the userin determining a course of treatment for the patient.
 17. The method ofclaim 14, wherein the guidance provided to the user is capable of beingoverridden by the user and wherein the guidelines are dynamicallyupdated based on user input.
 18. In a medical support system includingan input device for user inputs relating to a medical process and anoutput device for displaying the results of the medical process to auser, a memory for storing the medical process and medical data, and aprocessor operating under control of the medical process and the userinputs, a method for providing support for a medical practitionerperforming a medical process relating to diagnosis and treatment of amedical condition, the method comprising: storing at least one medicalrecord relating to a patient; storing at least one medical supportdatabase including medical guidelines for the diagnosis and treatment ofthe medical condition; and performing a medical support processincluding; providing at least one process form providing an interfacebetween a user and the process operations of the process phase, eachprocess form including fields for passing user inputs to the processoperations and for displaying the results of the process operations tothe user; and providing at least one support process responsive to userinputs, the medical record and the guidelines for performing the processoperations, wherein the support processes execute an interactivedialogue between the medical support process and the user to provideguidance to the user in performing the medical support process accordingto the guidelines and dependent upon the user inputs and the medicalrecord, wherein the guidance provided to the user is capable of beingoverridden by the user and wherein the guidelines are dynamicallyupdated based on user input.
 19. The method of claim 18 for providingsupport for a medical practitioner performing the medical process,wherein a medical support process includes: a data phase for enteringnew information and reviewing historical information pertaining to themedical condition of the patient for the purposes of the medical supportprocess; and an assessment phase for evaluation of the patient presentmedical condition based upon the information from the data phase and theguidelines for the diagnosis and treatment of the medical condition. 20.The method of claim 19 for providing support for a medical practitionerperforming the medical process, wherein a medical support processfurther includes: a recommendations phase including process operationsand guidelines to assist the user in determining a course of treatmentfor the patient.
 21. The method of claim 18 for providing support for amedical practitioner performing the medical process, further comprisingthe step of translating between medical terms displayed to and enteredby a user and corresponding equivalent but different medical termsemployed in the support operations, wherein the translation is abi-directional translation between medical terms displayed to andentered by a user and corresponding equivalent but different medicalterms employed in the support operations.
 22. The method of claim 18,wherein user input used to override the guidance is entered in themedical record.